Reported Mar 10, 2021 · Ongoing
Captivator/Captiflex/Sensation Short Throw Single-Use Polypectomy Snares Outer box UPN, Inner pouch UPN
Boston Scientific Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Boston Scientific Corporation · 100 Boston Scientific Way · Marlborough, MA · 01752-1234
Is this the product you have?
Captivator/Captiflex/Sensation Short Throw Single-Use Polypectomy Snares Outer box UPN, Inner pouch UPN
11 of 11 products
| # | Product as published |
|---|---|
| 1 | M00560311 (Box 5), M00560310 |
| 2 | M00560321 (Box 5), M00560320 |
| 3 | M00562651 (Box 5), M00562650 |
| 4 | M00562652 (Box 20), M00562650 |
| 5 | M00562671 (Box 5), M00562670 |
| 6 | M00562672 (Box 20), M00562670 |
| 7 | M00562673 (Box 40), M00562670 |
| 8 | M00562691 (Box 5) |
| 9 | M00562690 |
| 10 | M00562692 (Box 20), M00562690 |
| 11 | M00562693 (Box 40), M00562690. |
- Lot codes and dates
- Outer box GTIN08714729283904
- Inner pouch GTIN
08714729747598 Lot/Batch#: 248182782490682325042455
- Outer box GTIN08714729283928
- Inner pouch GTIN
08714729747611 Lot/Batch#: 246857662481714524899710247397862500673524861901
- Outer box GTIN08714729158110
- Inner pouch GTIN
08714729748069 Lot/Batch#: 246857642489005124824132
- Outer box GTIN08714729268802
- Inner pouch GTIN08714729748069 Lot/Batch#: 25023345
- Outer box GTIN08714729158141
- Inner pouch GTIN
08714729748083 Lot/Batch#: 246997182493962624861739
- Outer box GTIN08714729268819
- Inner pouch GTIN
08714729748083 Lot/Batch#: 248241342500672924709534
- Outer box GTIN08714729501664
- Inner pouch GTIN
08714729748083 Lot/Batch#: 250232032469782224739587249422922490921424824136
- Outer box GTIN08714729158158
- Inner pouch GTIN
08714729748106 Lot/Batch#: 248566362492764224699218
- Outer box GTIN08714729268826
- Inner pouch GTIN
08714729748106 Lot/Batch#: 248357092481860525023343
- Outer box GTIN08714729501671
- Inner pouch GTIN
08714729748106 Lot/Batch#: 249092162475883224872119249941712504839724751262492943124995438
- Amount recalled
- 335,788 units total (Domestic: 222,882, Foreign: 112,906)
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
Packaging Incomplete Seal. Users noted an incomplete pouch seal prior to using the device in a patient.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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